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Adamas Pharmaceuticals Presents Positive Phase 2/3 Results For ADS-5102 For The Treatment Of Levodopa-Induced Dyskinesia (LID) In Parkinson's Disease
Date:6/18/2013

placebo. The study enrolled 83 subjects who were randomized in a 1:1:1:1 ratio to the four treatment groups: placebo, 260 mg ADS-5102, 340 mg ADS-5102 and 420 mg ADS-5102. At the 340 mg dose of ADS-5102, a treatment difference of 11 points (reduction in LID) was observed (p=0.005). The 420 mg dose of ADS-5102 also met statistical significance with a treatment difference of 10 points (p=0.013). While the lowest dose tested of 260 mg ADS-5102 reduced UDysRS by 5.6 points, it did not achieve statistical significance at week 8 (p=0.159). Consistent with the changes observed in the UDysRS, ADS-5102 also demonstrated statistically significant functional improvement in dyskinesia as assessed by the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS, item 4.2), a measure of the degree of impact that dyskinesia has on the patient's daily function in terms of activities and social interactions. In addition, subjects reported a statistically significant increase of approximately three hours in "ON Time without troublesome dyskinesia" compared to placebo at week 8 across all dose levels.

The adverse events (AEs) reported in this study were consistent with Parkinson's disease and the known amantadine safety profile. Treatment emergent AEs were common in all treatment groups, and most were mild to moderate in severity. The most commonly reported AEs were constipation, dizziness, dry mouth, hallucination, fall, confusional state, headache, nausea, and asthenia, each reported in two or more subjects in the active treatment groups. Sixteen subjects (19%) discontinued treatment. Two subjects withdrew from the placebo group due to non-study drug-related reasons. The remainder of the discontinuations from the study were attributed to adverse events (260 mg, three subjects, 340 mg three subjects and 420 mg, eight subjects).

Additional EASED Study Results
In addition to the results reported above, the EASED study also assessed the change from baseline in UDysRS T
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SOURCE Adamas Pharmaceuticals, Inc.
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